Core Set of Patient-Reported Outcome Measures for Measuring Quality of Life in Clinical Obesity Care.

PURPOSE: The focus of measuring success in obesity treatment is shifting from weight loss to patients' health and quality of life. The objective of this study was to select a core set of patient-reported outcomes and patient-reported outcome measures to be used in clinical obesity care. MATERIALS AND METHODS: The Standardizing Quality of Life in Obesity Treatment III, face-to-face hybrid consensus meeting, including people living with obesity as well as healthcare providers, was held in Maastricht, the Netherlands, in 2022. It was preceded by two prior multinational consensus meetings and a systematic review. RESULTS: The meeting was attended by 27 participants, representing twelve countries from five continents. The participants included healthcare providers, such as surgeons, endocrinologists, dietitians, psychologists, researchers, and people living with obesity, most of whom were involved in patient representative networks. Three patient-reported outcome measures (patient-reported outcomes) were selected: the Impact of Weight on Quality of Life-Lite (self-esteem) measure, the BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), and the Quality of Life for Obesity Surgery questionnaire (excess skin). No patient-reported outcome measure was selected for stigma. CONCLUSION: A core set of patient-reported outcomes and patient-reported outcome measures for measuring quality of life in clinical obesity care is established incorporating patients' and experts' opinions. This set should be used as a minimum for measuring quality of life in routine clinical practice. It is essential that individual patient-reported outcome measure scores are shared with people living with obesity in order to enhance patient engagement and shared decision-making.

A New Procedure-Based Assessment of Operative Skills in Gastric Bypass Surgery, Evaluated by Video Fragment Rating.

PURPOSE: Feedback on technical and procedural skills is essential during the training of residents and fellows. The aim of this study was to assess the performance of a newly created instrument for the assessment of operative skills using laparoscopic Roux-en-Y gastric bypass (LRYGB) video fragments. MATERIALS AND METHODS: A new procedure-based assessment (PBA) was created by combining LRYGB key steps with a 5-point independence scale. LRYGB performed by residents and surgeons with different levels of expertise were video recorded. Fragments of the pouch creation, gastro-jejunostomy and jejunojejunostomy, were review by 12 expert bariatric surgeons and the operative skills assessed with the PBA, Objective Structured Assessment of Technical Skill (OSATS), and the Bariatric OSATS (BOSATS). The PBA was compared to the OSATS and BOSATS. Mean scores for all items of the different assessments were summarized and compared using a T-test. RESULTS: The scores of the procedural steps were combined and compared for all levels. The mean scores for beginner, intermediate, and expert level were 2.71, 3.70, and 3.90 for the PBA; for the OSATS 1.84, 2.86, and 3.44; and for the BOSATS 2.78, 3.56, and 4.19. Each of these assessments differentiated between the three skill levels (all p < 0.05). CONCLUSION: The PBA discriminates well between different levels of operative skills. Similar patterns were found for the OSATS and BOSATS, showing that the randomly selected video fragments are representative samples for assessing skill level. Future research will demonstrate whether these results can be extrapolated to clinical training, and which scores allow for procedure certification.

Using the BODY-Q to develop a prospective cohort of patients undergoing bariatric and body contouring surgery: A study protocol.

The BODY-Q is a patient-reported outcome measure designed to measure health-related quality of life, satisfaction with appearance and experience with healthcare in patients with obesity who undergo bariatric surgery and/or body contouring surgery after massive weight loss. The aim of this study is to collect long term PRO-data from patients living with obesity undergoing bariatric surgery, comparing patient undergoing or not undergoing body contouring surgery. This study will be a multicentre, prospective longitudinal cohort study with participation of three bariatric medical centres in the Netherlands. The BODY-Q will be used to measure the satisfaction with appearance and HRQL. Patients undergoing bariatric surgery, age >18 years and <65 years and who are able to read and understand Dutch can be included. All bariatric procedures are eligible for inclusion. Administration of the questionnaires will be done preoperatively for bariatric and body contouring surgery as well as at 3, 12, 24, 36, 48 and 60 months post-operatively. Patient-reported outcomes measurements are becoming more important with the shift to patient-centred healthcare. The collected longitudinal data can be helpful in determining the effectiveness and value of bariatric and body contouring surgery from the patient's perspective, and can contribute to patient tailored postoperative care.

Adjustable Gastric Banding Conversion to One Anastomosis Gastric Bypass: Data Analysis of a Multicenter Database.

INTRODUCTION: One anastomosis gastric bypass (OAGB) has been proposed as a rescue technique for laparoscopic adjustable gastric banding (LAGB) poor responders. AIM: We sought to analyze, complications, mortality, and medium-term weight loss results after LAGB conversion to OAGB. METHODS: Data analysis of an international multicenter database. RESULTS: One hundred eighty-nine LAGB-to-OAGB operations were retrospectively analyzed. Eighty-seven (46.0%) were converted in one stage. Patients operated on in two stages had a higher preoperative body mass index (BMI) (37.9 vs. 41.3 kg/m2, p = 0.0007) and were more likely to have encountered technical complications, such as slippage or erosions (36% vs. 78%, p < 0.0001). Postoperative complications occurred in 4.8% of the patients (4.6% and 4.9% in the one-stage and the two-stage group, respectively). Leak rate, bleeding episodes, and mortality were 2.6%, 0.5%, and 0.5%, respectively. The final BMI was 30.2 at a mean follow-up of 31.4 months. Follow-up at 1, 3, and 5 years was 100%, 88%, and 70%, respectively. CONCLUSION: Conversion from LAGB to OAGB is safe and effective. The one-stage approach appears to be the preferred option in non-complicate cases, while the two-step approach is mostly done for more complicated cases.

The relation between postprandial glucagon-like peptide-1 release and insulin sensitivity before and after bariatric surgery in humans with class II/III obesity.

BACKGROUND: Glucagon-like peptide-1 (GLP-1) receptor agonist treatment is beneficial for the human glucose metabolism, and GLP-1 secretion is greatly enhanced following Roux-en-Y gastric bypass (RYGB). OBJECTIVES: To elucidate the relationship between GLP-1 concentrations and insulin sensitivity in subjects with class II/III obesity without diabetes and to assess the relation between GLP-1 and the improvements in glucose metabolism following RYGB. SETTING: Clinical research facility in a university hospital. METHODS: We recruited 35 patients scheduled for RYGB and assessed their plasma GLP-1, insulin, and glucose responses to a high-fat mixed meal. Basal and insulin-mediated glucose fluxes were determined during a 2-step hyperinsulinemic-euglycemic clamp with stable isotope-labeled tracers. Out of 35 subjects, 10 were studied both before surgery and at 1 year of follow-up. RESULTS: Plasma GLP-1 increased following the high-fat mixed meal. Postprandial GLP-1 excursions correlated positively with hepatic and peripheral insulin sensitivity, but not with body mass index. At 1 year after RYGB, participants had lost 24% ± 6% of their body weight. Plasma GLP-1, insulin, and glucose levels peaked earlier and higher after the mixed meal. The positive association between the postprandial GLP-1 response and peripheral insulin sensitivity persisted. CONCLUSIONS: Postprandial GLP-1 concentrations correlate with insulin sensitivity in subjects with class II/III obesity without diabetes before and 1 year after RYGB. Increased GLP-1 signaling in postbariatric patients may, directly or indirectly, contribute to the observed improvements in insulin sensitivity and metabolic health.

Hepatic Insulin Resistance Is Not Pathway Selective in Humans With Nonalcoholic Fatty Liver Disease.

OBJECTIVE: Both glucose and triglyceride production are increased in type 2 diabetes and nonalcoholic fatty liver disease (NAFLD). For decades, the leading hypothesis to explain these paradoxical observations has been selective hepatic insulin resistance wherein insulin drives de novo lipogenesis (DNL) while failing to suppress glucose production. Here, we aimed to test this hypothesis in humans. RESEARCH DESIGN AND METHODS: We recruited obese subjects who met criteria for bariatric surgery with (n = 16) or without (n = 15) NAFLD and assessed 1) insulin-mediated regulation of hepatic and peripheral glucose metabolism using hyperinsulinemic-euglycemic clamps with [6,6-2H2]glucose, 2) fasting and carbohydrate-driven hepatic DNL using deuterated water (2H2O), and 3) hepatocellular insulin signaling in liver biopsy samples collected during bariatric surgery. RESULTS: Compared with subjects without NAFLD, those with NAFLD demonstrated impaired insulin-mediated suppression of glucose production and attenuated-not increased-glucose-stimulated/high-insulin lipogenesis. Fructose-stimulated/low-insulin lipogenesis was intact. Hepatocellular insulin signaling, assessed for the first time in humans, exhibited a proximal block in insulin-resistant subjects: Signaling was attenuated from the level of the insulin receptor through both glucose and lipogenesis pathways. The carbohydrate-regulated lipogenic transcription factor ChREBP was increased in subjects with NAFLD. CONCLUSIONS: Acute increases in lipogenesis in humans with NAFLD are not explained by altered molecular regulation of lipogenesis through a paradoxical increase in lipogenic insulin action; rather, increases in lipogenic substrate availability may be the key.

A randomized controlled trial comparing oral and intravenous iron supplementation after Roux-en-Y gastric bypass surgery.

BACKGROUND: Iron deficiency (ID) is one of the most common postoperative deficiencies that may develop after Roux-en-Y gastric bypass (RYGB). The optimal mode of treatment is uncertain. AIM: To compare the efficacy of oral ferrous fumarate (FF), oral ferrous gluconate (FG), and a single intravenous infusion of ferric carboxymaltose (FCM) in women with ID after RYGB. METHODS: Multicenter randomized controlled trial including 120 women with a serum ferritin <20 µg/l during follow-up after RYGB. They were randomized into three groups: 41 patients were treated with FF 200 mg three times a day (total daily dose: 195 mg elemental iron), 39 received FG 695 mg twice a day (total daily dose: 160 mg elemental iron) for three months, and 39 patients were treated with a single intravenous dose of FCM (1000 mg elemental iron). Serum ferritin levels were measured at six weeks, and three, six and twelve months after the start of supplementation. RESULTS: At three months, persistence of ID was observed in 29.4% and 42.4% of the patients treated with FF and FG, respectively, but in none of those treated with FCM (p < 0.001). Over the next nine months, recurrence of ID was observed in 56.5% of patients treated with FF, in 52.9% treated with FG, and in 27.8% of those treated with FCM. Adverse effects were most common during oral treatment. CONCLUSION: In women developing ID after RYGB, a single dose of intravenous FCM is more effective and better tolerated than the standard treatment with either FF or FG. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE: The study was registered at clinicaltrials.gov under number NCT02271997.

Roux-en-Y gastric bypass, sleeve gastrectomy, or one anastomosis gastric bypass as rescue therapy after failed adjustable gastric banding: a multicenter comparative study.

BACKGROUND: To date, laparoscopic adjustable gastric banding remains the third most commonly performed surgical procedure for weight loss. Some patients fail to get acceptable outcomes and undergo revisional surgery at rates ranging from 7% to 60%. Roux-en-Y gastric bypass (RYGB), one anastomosis gastric bypass (OAGB), and sleeve gastrectomy (SG) are among the most common salvage options for failed laparoscopic adjustable gastric banding. OBJECTIVE: To compare the outcomes of converting failed laparoscopic adjustable gastric banding to RYGB, OAGB, or SG. METHODS: Data collected from 7 experienced bariatric centers around the world were retrospectively collected, reviewed, and analyzed. Final body mass index (BMI), change in BMI, percentage excess BMI loss, and major complications with particular attention to leaks, hemorrhage, and mortality were reported. RESULTS: Of 1219 patients analyzed, 74% underwent RYGB, 16% underwent OAGB, and 10% underwent SG after banding failure. The mean age was 38 years (±10 yr), and 82% of patients were women. The mean follow-up was 33 months. The follow-up rate was 100%, 87%, and 52% at 1, 3, and 5 years, respectively. At the latest follow-up, percentage excess BMI loss >50% was achieved by 75% of RYGB, 85% of OAGB, and 67% of SG patients. Postoperative complications occurred in 13% of patients after RYGB, 5% after OAGB, and 15% after SG. CONCLUSION: Our data show that it is possible to achieve or maintain significant weight loss with an acceptable complication rate with all 3 surgical options.

A Delphi Consensus of the Crucial Steps in Gastric Bypass and Sleeve Gastrectomy Procedures in the Netherlands.

PURPOSE: Bariatric procedures are technically complex and skill demanding. In order to standardize the procedures for research and training, a Delphi analysis was performed to reach consensus on the practice of the laparoscopic gastric bypass and sleeve gastrectomy in the Netherlands. METHODS: After a pre-round identifying all possible steps from literature and expert opinion within our study group, questionnaires were send to 68 registered Dutch bariatric surgeons, with 73 steps for bypass surgery and 51 steps for sleeve gastrectomy. Statistical analysis was performed to identify steps with and without consensus. This process was repeated to reach consensus of all necessary steps. RESULTS: Thirty-eight participants (56%) responded in the first round and 32 participants (47%) in the second round. After the first Delphi round, 19 steps for gastric bypass (26%) and 14 for sleeve gastrectomy (27%) gained full consensus. After the second round, an additional amount of 10 and 12 sub-steps was confirmed as key steps, respectively. Thirteen steps in the gastric bypass and seven in the gastric sleeve were deemed advisable. Our expert panel showed a high level of consensus expressed in a Cronbach's alpha of 0.82 for the gastric bypass and 0.87 for the sleeve gastrectomy. CONCLUSIONS: The Delphi consensus defined 29 steps for gastric bypass and 26 for sleeve gastrectomy as being crucial for correct performance of these procedures to the standards of our expert panel. These results offer a clear framework for the technical execution of these procedures.

Trocar port scar quality in morbidly obese patients after bariatric surgery.

BACKGROUND: Patient satisfaction of scar quality and their influence on health-related quality of life (HRQoL) have never been investigated in morbidly obese patients. OBJECTIVES: Our objectives were (1) to assess scar quality 1 year post laparoscopic bariatric surgery by means of the Patient and Observer Scar Assessment Scale (POSAS), and (2) to examine the influence of patients' perception of scar quality on patients' HRQoL. SETTING: A large Bariatric Center of Excellence in the Netherlands. METHODS: This was a descriptive pilot study of patients who underwent primary laparoscopic bariatric surgery. One year after surgery, patients and 2 observers completed the POSAS. HRQoL was assessed by using the RAND-36. Agreement of POSAS scores between patients and observers was calculated with intraclass correlation coefficient. Correlations between POSAS scores and HRQoL scores were calculated with Spearman's rho. RESULTS: A total of 50 patients were included. Patients scored their scar quality worse than observers (21 versus 15-16), particularly on visual parameters (4-5 versus 2-3). Patients and observers showed poor agreement on all POSAS items (intraclass correlation coefficient = .16-.32). No significant correlations were detected between POSAS and HRQoL scores. CONCLUSION: While patient scar quality satisfaction was relatively low after bariatric surgery, these outcomes were not correlated with HRQoL. Bariatric surgeons should be aware that patients could have a different view on scar quality compared with them. This realization is important to manage patient expectations regarding scar quality after bariatric surgery. Effective communication may improve patient satisfaction as an outcome.

Patients' preferences for information in bariatric surgery.

BACKGROUND: The decision to undergo bariatric surgery is multifactorial and made both by patient and doctor. Information is of the utmost importance for this decision. OBJECTIVE: To investigate the bariatric surgery patient's preferences regarding information provision in bariatric surgery. SETTING: A teaching hospital, bariatric center of excellence in Amsterdam, the Netherlands. METHODS: All patients who underwent a primary laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy between September 2013 and September 2014 were approached by mail to participate. A questionnaire was used to elicit patient preferences for the content and format of information. Sociodemographic characteristics, clinicopathologic factors, and psychologic factors were explored as predictors for specific preferences. RESULTS: Of the 356 eligible patients, 112 (31.5%) participated. The mean age was 49.2 (±10.7) years, and 91 (81.3%) patients were female. Patients deemed the opportunity to ask questions (96.4%) the most important feature of the consult, followed by a realistic view on expectations-for example, results of the procedure (95.5%) and information concerning the consequences of surgery for daily life (89.1%). Information about the risk of complications on the order of 10% was desired by 93% of patients; 48% desired information about lower risks (.1%). Only 25 patients (22.3%) desired detailed information concerning their weight loss after surgery. CONCLUSION: Bariatric patients wished for information about the consequences of surgery on daily life, whereas the importance of information concerning complications decreased when their incidence lessened.

Bariatric Surgery Worldwide: Baseline Demographic Description and One-Year Outcomes from the Second IFSO Global Registry Report 2013-2015.

BACKGROUND: Five International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) surveys since 1998 have estimated the volume and type of bariatric surgery being done in constituent member countries. These reports did not include baseline demographic descriptions. METHODS: An IFSO Global Registry pilot project in 2014 demonstrated that it was possible to amalgamate large numbers of individual patient data from different local and national database systems. Here we describe demographic data from the second report for 54,490 patients from 31 countries operated in the 3 calendar years 2013-2015 and follow up data from 66,560 of 112,544 patients in 2009-2015. RESULTS: Most procedures (97.8%) were performed laparoscopically and 73.3% (95% CI: 73.0-73.7%, range 54.2 to 80.3%) were female. The average age was 42.0 years (95% CI 41.9-42.1, inter-quartile range 33.0-51.0 years) and the median body mass index was 43.3 kg/m2 (inter-quartile range 39.4-48.8 kg/m2). Before surgery, 22.0% patients had type 2 diabetes (inter-country variation 7.4-63.2%); 31.9% were hypertensive (15.8-92.7%); 17.6% had depression (0.0-46.3%); 27.8% took medication for musculoskeletal pain (0.0-58.9%); 18.9% had sleep apnea (0.0-63.2%); and 29.6% of patients had gastro-esophageal reflux disease (9.1-90.9%). Gastric bypass was the most prevalent operation (49.4%), followed by sleeve gastrectomy (40.7%) and gastric banding (5.5%). The 1-year total weight loss for patients with available data was 30.53% (95% CI: 30.22-30.84%) and in the cohort 2009-15 was 30.4% with a follow-up rate of 59.14%. In the 2009-2015 cohort, 64.7% of patients on treatment for diabetes preoperatively were not on treatment postoperatively. CONCLUSIONS: There is widespread variation in access to surgery and in baseline patient characteristics in the countries submitting data to the IFSO Global Registry.

Influence of continuous positive airway pressure on postoperative leakage in bariatric surgery.

BACKGROUND: Obstructive sleep apnea (OSA) affects two third of morbidly obese individuals undergoing bariatric surgery. Perioperative usage of continuous positive airway pressure (CPAP) is advised for moderately and severe OSA to avoid respiratory failure and cardiac events. CPAP increases the air pressure in the upper airway, but also may elevate the air pressure in the esophagus and stomach. Concern exists that this predisposes to mechanical stress resulting in suture or staple line disruption (further referred to as suture line disruption). OBJECTIVES: To evaluate whether perioperative CPAP usage is associated with an increased risk of suture line disruption after bariatric surgery. SETTING: Obesity Center Amsterdam, OLVG-west, Amsterdam, the Netherlands. METHODS: All patients who underwent bariatric surgery including a suture line were eligible for inclusion. Only patients with information regarding OSA severity as defined by the apnea-hypopnea-index and postoperative CPAP usage were included. RESULTS: From November 2007 to August 2016, postoperative CPAP status was documented in 2135 patients: 497 (23.3%) used CPAP postoperatively, whereas 1638 (76.7%) used no CPAP. Mean body mass index was 44.1 kg/m2 (standard deviation 6.6). Suture line disruption occurred in 25 patients (1.2%). The leakage rate was not associated with CPAP usage (8 [1.6%] in CPAP group versus 17 [1%] in non-CPAP group, P = .300). CPAP was no risk factor for suture line disruption in multivariable analysis as well. CONCLUSION: Postoperative CPAP does not appear to increase the risk of suture line disruption in bariatric surgery. CPAP is recommended in all patients with moderate or severe OSA who undergo bariatric surgery.

Obstructive sleep apnea and bariatric surgical guidelines: summary and update.

PURPOSE OF REVIEW: Increasing numbers of bariatric surgical procedures and the high prevalence of obstructive sleep apnea (OSA) in this population have resulted in a growing interest in the perioperative management of OSA in bariatric surgery. This review provides a summary of the first consensus guideline on this topic as well as an update of the newest literature available. RECENT FINDINGS: All bariatric patients should be screened for OSA and obesity hypoventilation syndrome (OHS) to reduce the risk of perioperative complications. Intraoperative precautions are preoxygenation, induction and intubation in ramped position, continuous positive airway pressure (CPAP) and positive end-expiratory pressure during induction, maintenance of low tidal volumes during surgery, multimodal anesthesia and analgesia with avoidance of opioids and extubation when patients are free of neuromuscular blockage. CPAP therapy and continuous monitoring with a minimum of pulse oximetry is recommended in the early postoperative period. SUMMARY: Multiple precautions exist to minimize the risk of cardiopulmonary complications and to enhance recovery after surgery. A combination of these procedures seems to provide optimal perioperative care of OSA patients undergoing bariatric surgery. Nearly 75% of recommendations are based on low quality of evidence, indicating the high value of experts' opinion and potential for future research.

Current Techniques of Teaching and Learning in Bariatric Surgical Procedures: A Systematic Review.

OBJECTIVE: The gastric sleeve resection and gastric bypass are the 2 most commonly performed bariatric procedures. This article provides an overview of current teaching and learning methods of those techniques in resident and fellow training. DESIGN: A database search was performed on Pubmed, Embase, and the Education Resources Information Center (ERIC) to identify the methods used to provide training in bariatric surgery worldwide. After exclusion based on titles and abstracts, full texts of the selected articles were assessed. Included articles were reviewed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS: In total, 2442 titles were identified and 14 full text articles met inclusion criteria. Four publications described an ex vivo training course, and 6 focused on at least 1 step of the gastric bypass procedure. Two randomized controlled trials (RCT) provided high-quality evidence on training aspects. Surgical coaching caused significant improvement of Bariatric Objective Structured Assessment of Technical Skills (BOSATS) scores (3.60 vs. 3.90, p = 0.017) and reduction of technical errors (18 vs. 10, p = 0.003). A preoperative warm-up increased global rating scales (GRS) scores on depth perception (p = 0.02), bimanual dexterity (p = 0.01), and efficiency of movements (p = 0.03). CONCLUSION: Stepwise education, surgical coaching, warming up, Internet-based knowledge modules, and ex vivo training courses are effective in relation to bariatric surgical training of residents and fellows, possibly shortening their learning curves.

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: study protocol for a randomized controlled trial (UPGRADE trial).

BACKGROUND: The number of bariatric interventions for morbid obesity is increasing worldwide. Rapid weight loss is a major risk factor for gallstone development. Approximately 11 % of patients who underwent Roux-en-Y gastric bypass develop symptomatic gallstone disease. Gallstone disease can lead to severe complications and often requires hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation of gallstones after bariatric surgery. However, randomized controlled trials with symptomatic gallstone disease as primary endpoint have not been conducted. Currently, major guidelines make no definite statement about postoperative UDCA prophylaxis and most bariatric centers do not prescribe UDCA. METHODS: A randomized, placebo-controlled, double-blind multicenter trial will be performed for which 980 patients will be included. The study population consists of consecutive patients scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy in three bariatric centers in the Netherlands. Patients will undergo a preoperative ultrasound and randomization will be stratified for pre-existing gallstones and for type of surgery. The intervention group will receive UDCA 900 mg once daily for six months. The placebo group will receive similar-looking placebo tablets. The primary endpoint is symptomatic gallstone disease after 24 months, defined as admission or hospital visit for symptomatic gallstone disease. Secondary endpoints consist of the development of gallstones on ultrasound at 24 months, number of cholecystectomies, side-effects of UDCA and quality of life. Furthermore, cost-effectiveness, cost-utility and budget impact analyses will be performed. DISCUSSION: The UPGRADE trial will answer the question whether UDCA reduces the incidence of symptomatic gallstone disease after Roux-en-Y gastric bypass or sleeve gastrectomy. Furthermore it will determine if treatment with UDCA is cost-effective. TRIAL REGISTRATION: Netherlands Trial Register (trialregister.nl) 6135 . Date registered: 21-Nov-2016.

The FGF21 response to fructose predicts metabolic health and persists after bariatric surgery in obese humans.

OBJECTIVE: Fructose consumption has been implicated in the development of obesity and insulin resistance. Emerging evidence shows that fibroblast growth factor 21 (FGF21) has beneficial effects on glucose, lipid, and energy metabolism and may also mediate an adaptive response to fructose ingestion. Fructose acutely stimulates circulating FGF21 consistent with a hormonal response. We aimed to evaluate whether fructose-induced FGF21 secretion is linked to metabolic outcomes in obese humans before and after bariatric surgery-induced weight loss. METHODS: We recruited 40 Roux-en-Y gastric bypass patients and assessed the serum FGF21 response to fructose (75-g fructose tolerance test) and basal and insulin-mediated glucose and lipid fluxes during a 2-step hyperinsulinemic-euglycemic clamp with infusion of [6,6-2H2] glucose and [1,1,2,3,3-2H5] glycerol. Liver biopsies were obtained during bariatric surgery. Nineteen subjects underwent the same assessments at 1-year follow-up. RESULTS: Serum FGF21 increased 3-fold at 120 min after fructose ingestion and returned to basal levels at 300 min. Neither basal FGF21 nor the fructose-FGF21 response correlated with liver fat content or liver histopathology, but increased levels were associated with elevated endogenous glucose production, increased lipolysis, and peripheral/muscle insulin resistance. At 1-year follow-up, subjects had lost 28 ± 6% of body weight and improved in all metabolic outcomes, but fructose-stimulated FGF21 dynamics did not markedly differ from the pre-surgical state. The association between increased basal and stimulated FGF21 levels with poor metabolic health was no longer present after weight loss. CONCLUSIONS: Fructose ingestion in obese humans stimulates FGF21 secretion, and this response is related to systemic metabolism. Further studies are needed to establish if FGF21 signaling is (patho)physiologically involved in fructose metabolism and metabolic health.

Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multicentre trial.

BACKGROUND: Treatment of patients with ileocaecal Crohn's disease who have not responded to conventional therapy is commonly scaled up to biological agents, but surgery can also offer excellent short-term and long-term results. We compared laparoscopic ileocaecal resection with infliximab to assess how they affect health-related quality of life. METHODS: In this randomised controlled, open-label trial, in 29 teaching hospitals and tertiary care centres in the Netherlands and the UK, adults with non-stricturing, ileocaecal Crohn's disease, in whom conventional therapy has failed were randomly allocated (1:1) by an internet randomisation module with biased-coin minimisation for participating centres and perianal fistula to receive laparoscopic ileocaecal resection or infliximab. Eligible patients were aged 18-80 years, had active Crohn's disease of the terminal ileum, and had not responded to at least 3 months of conventional therapy with glucocorticosteroids, thiopurines, or methotrexate. Patients with diseased terminal ileum longer than 40 cm or abdominal abscesses were excluded. The primary outcome was quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ) at 12 months. Secondary outcomes were general quality of life, measured by the Short Form-36 (SF-36) health survey and its physical and mental component subscales, days unable to participate in social life, days on sick leave, morbidity (additional procedures and hospital admissions), and body image and cosmesis. Analyses of the primary outcome were done in the intention-to-treat population, and safety analyses were done in the per-protocol population. This trial is registered at the Dutch Trial Registry (NTR1150). FINDINGS: Between May 2, 2008, and October 14, 2015, 73 patients were allocated to have resection and 70 to receive infliximab. Corrected for baseline differences, the mean IBDQ score at 12 months was 178·1 (95% CI 171·1-185·0) in the resection group versus 172·0 (164·3-179·6) in the infliximab group (mean difference 6·1 points, 95% CI -4·2 to 16·4; p=0·25). At 12 months, the mean SF-36 total score was 112·1 (95% CI 108·0-116·2) in the resection group versus 106·5 (102·1-110·9) in the infliximab group (mean difference 5·6, 95% CI -0·4 to 11·6), the mean physical component score was 47·7 (45·7-49·7) versus 44·6 (42·5-46·8; mean difference 3·1, 4·2 to 6·0), and the mean mental component score was 49·5 (47·0-52·1) versus 46·1 (43·3-48·9; mean difference 3·5, -0·3 to 7·3). Mean numbers of days of sick leave were 3·4 days (SD 7·1) in the resection group versus 1·4 days (4·7) in the infliximab group (p<0·0001), days not able to take part in social life were 1·8 days (6·3) versus 1·1 days (4·5; p=0·20), days of scheduled hospital admission were 6·5 days (3·8) versus 6·8 days (3·2; p=0·84), and the number of patients who had unscheduled hospital admissions were 13 (18%) of 73 versus 15 (21%) of 70 (p=0·68). Body-image scale mean scores in the patients who had resection were 16·0 (95% CI 15·2-16·8) at baseline versus 17·8 (17·1-18·4) at 12 months, and cosmetic scale mean scores were 17·6 (16·6-18·6) versus 18·6 (17·6-19·6). Surgical intervention-related complications classified as IIIa or worse on the Clavien-Dindo scale occurred in four patients in the resection group. Treatment-related serious adverse events occurred in two patients in the infliximab group. During a median follow-up of 4 years (IQR 2-6), 26 (37%) of 70 patients in the infliximab group had resection, and 19 (26%) of 73 patients in the resection group received anti-TNF. INTERPRETATION: Laparoscopic resection in patients with limited (diseased terminal ileum <40 cm), non-stricturing, ileocaecal Crohn's disease in whom conventional therapy has failed could be considered a reasonable alternative to infliximab therapy. FUNDING: Netherlands Organisation for Health Research and Development.

Unexplained abdominal pain in morbidly obese patients after bariatric surgery.

BACKGROUND: There is an overall complication rate of 6.3%-10% after bariatric surgery. After ruling out anatomic/physical causes, there is a substantial group of patients who develop unexplained postsurgical abdominal pain. OBJECTIVES: To inventory the prevalence of unexplained abdominal pain after laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy and to determine predictive factors for unexplained abdominal pain. SETTING: Obesity Center Amsterdam, Amsterdam, the Netherlands. METHODS: A retrospective study in a prospective database was performed. Baseline characteristics and postoperative course were evaluated. RESULTS: A total of 1788 patients underwent laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy between November 2007 and April 2015. The average follow-up consisted of 33.5 months, without loss to follow-up. Abdominal pain was presented in 387 patients (21.6%). The study population consisted of 337 women (87.1%) and 50 men (12.9%); the mean age was 43.3 years (standard deviation 10.1) and the median preoperative body mass index was 43.7 kg/m². An explanation for abdominal pain was found in 246 of 387 patients (63.6%), whereas no explanation was found in 133 patients (34.4%). Revisional surgery was a significant predictor for unexplained pain (odds ratio 1.7; confidence interval 1.0-2.8; P = 0.037). CONCLUSION: A total of 133 patients (7.4%) experienced unexplained abdominal pain after laparoscopic bariatric surgery. Revisional surgery was found to be a significant predictive factor for this outcome. Present study results suggest that postoperative unexplained abdominal pain is a significant morbidity and should be part of the informed consent. More research is needed regarding further diagnosis and management and treatment.

Perioperative management of obstructive sleep apnea in bariatric surgery: a consensus guideline.

BACKGROUND: The frequency of metabolic and bariatric surgery (MBS) is increasing worldwide, with over 500,000 cases performed every year. Obstructive sleep apnea (OSA) is present in 35%-94% of MBS patients. Nevertheless, consensus regarding the perioperative management of OSA in MBS patients is not established. OBJECTIVES: To provide consensus based guidelines utilizing current literature and, when in the absence of supporting clinical data, expert opinion by organizing a consensus meeting of experts from relevant specialties. SETTING: The meeting was held in Amsterdam, the Netherlands. METHODS: A panel of 15 international experts identified 75 questions covering preoperative screening, treatment, postoperative monitoring, anesthetic care and follow-up. Six researchers reviewed the literature systematically. During this meeting, the "Amsterdam Delphi Method" was utilized including controlled acquisition of feedback, aggregation of responses and iteration. RESULTS: Recommendations or statements were provided for 58 questions. In the judgment of the experts, 17 questions provided no additional useful information and it was agreed to exclude them. With the exception of 3 recommendations (64%, 66%, and 66% respectively), consensus (>70%) was reached for 55 statements and recommendations. Several highlights: polysomnography is the gold standard for diagnosing OSA; continuous positive airway pressure is recommended for all patients with moderate and severe OSA; OSA patients should be continuously monitored with pulse oximetry in the early postoperative period; perioperative usage of sedatives and opioids should be minimized. CONCLUSION: This first international expert meeting provided 58 statements and recommendations for a clinical consensus guideline regarding the perioperative management of OSA patients undergoing MBS.